三款产品深度拓展拉美市场，复宏汉霖与巴西本土龙头药企达成合作 | 新闻稿

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关键词：达成合作合作

资讯来源：研发客

发布时间： 2022-05-13

2022年5月11日，复宏汉霖（2696.HK）宣布与巴西本土龙头药企Eurofarma Laboratórios S.A.（下称“Eurofarma”）公司签署许可协议，授予其在16个拉美地区国家对公司自主开发的利妥昔单抗汉利康^®、曲妥珠单抗汉曲优^®、贝伐珠单抗汉贝泰^®三款产品进行开发、生产和商业化权益。Eurofarma在面向拉美区域的创新药品引入和推广上具有丰富经验。此项合作的达成，不仅代表着复宏汉霖领先的产品品质和企业综合实力再获国际认可，更是公司加速国际化布局战略的进一步实践，为公司由biotech向biopharma的进化蓄势聚力。

根据协议，复宏汉霖将从此次交易中获得高达5050万美元的潜在收入，其中450万美元为首付款。Eurofarma将获得利妥昔单抗汉利康^®在墨西哥、危地马拉、巴拿马等12个国家的独家权益；曲妥珠单抗汉曲优®在墨西哥、智利、厄瓜多尔等11个国家的独家权益；贝伐珠单抗汉贝泰®在墨西哥、阿根廷、智利等15个国家的独家权益。此外，Eurofarma还将获得上述三款产品在巴西的半独家权益。

复宏汉霖总裁朱俊先生表示：“我们很荣幸可以与大洋彼岸的Eurofarma结成合作伙伴。以优质生物药造福全球病患，是复宏汉霖一贯遵循和坚守的理念。Eurofarma在拉美地区强大的业务网络和资源，将有力助推复宏汉霖产品在拉美地区的商业化进程及患者的用药可及性。希望我们的三款产品能够为更多拉美国家患者提供优质治疗选择，点亮他们生命的希望。”

Eurofarma公司创新业务副总裁Martha Penna女士表示：“我们对此次与复宏汉霖建立合作关系感到非常骄傲，这将有助于我们进一步扩大自身在生物类似药领域的覆盖，同时为我们将全球顶尖药物引入拉美地区的不懈努力增添动力。目前我们正双管齐下推进公司战略目标，一方面扩大我们的区域影响力以增加来自国际业务的收入，同时着力布局新锐技术，这将有助于我们成为药品创新方面的标杆之一。”

复宏汉霖立足患者需求，致力于凭借强大的产品研发、前沿的生产与质量体系及卓越的商业化能力，携手价值链上的伙伴积极布局拓展全球生物药市场。汉曲优^®（欧洲商品名：Zercepac^®）是首个中欧双批的国产单抗生物类似药，其与汉贝泰^®均由公司自建团队进行中国市场的商业化推广。汉曲优^®150mg/60mg双规格均已被纳入中国医保目录，迄今已惠及逾5万名患者。汉利康^®是中国首个生物类似药，自2019年获批上市以来已惠及超10万名中国患者。此外，复宏汉霖围绕汉曲优^®和汉利康^®两款产品前瞻性地开展了国际商业化布局，积极开拓海外市场。公司针对汉曲优^®携手全球商业合作伙伴Accord Healthcare、Cipla、Mabxience和雅各臣药业等国际一流的生物制药企业，全面布局美国、加拿大、欧洲以及众多新兴国家市场，覆盖全球80多个国家和地区。作为国产生物药“出海”代表，Zercepac^®（150mg）已于英国、德国、西班牙、法国、意大利、爱尔兰、匈牙利、瑞士等近20个欧洲国家和地区成功上市。不仅如此，公司已与哥伦比亚制药企业Farma de Colombia达成合作协议，以促进汉利康®在哥伦比亚、秘鲁、厄瓜多尔及委内瑞拉的商业化。包括本次与Eurofarma的合作在内，公司产品已触达19个拉美地区人口大国，覆盖逾90%的拉美人口。

关于Eurofarma Laboratórios S.A.

Eurofarma为一家于1972年在巴西成立的公司，主要于大健康领域从事生产和销售以提高人们生活质量的创新产品和服务，涉及处方药、非处方药、仿制药、医院领域及肿瘤领域。该公司提供逾700种产品，覆盖2000多个产品，并为42个医学专业提供服务。在巴西当地，公司涵盖100个治疗领域，市占率超70%。

Eurofarma业务遍及20个国家，其在巴西建有工业园区并在其他6个拉美国家设有工厂雇佣员工超过8100名。2021年公司的净销售额为71亿雷亚尔，比上一年增长 23%。

关于复宏汉霖

复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在中国上市5款产品，在欧洲上市1款产品，13项适应症获批，2个上市注册申请获得中国药监局受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，上海徐汇基地已获得中国和欧盟药品GMP认证，松江基地（一）也已获得中国GMP认证。

复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖20多种创新单克隆抗体，并全面推进基于自有抗PD-1单抗H药汉斯状^®的肿瘤免疫联合疗法。继国内首个生物类似药汉利康^®（利妥昔单抗）、中国首个自主研发的中欧双批单抗药物汉曲优^®（曲妥珠单抗，欧洲商品名：Zercepac^®）、汉达远^®（阿达木单抗）和汉贝泰^®（贝伐珠单抗）相继获批上市，创新产品汉斯状^®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤，其鳞状非小细胞肺癌和广泛期小细胞肺癌两项适应症的上市注册申请也正在审评中。公司亦同步就12个产品、9个免疫联合治疗方案在全球范围内开展20多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。

关于汉利康^®

复宏汉霖旗下首款产品汉利康^®于2019年2月正式获得中国国家药监局上市注册申请批准，成为中国首个根据2015年发布的《生物类似药研发与评价技术指导原则（试行）》开发并批准上市的生物类似药。目前，汉利康^®已获批治疗非霍奇金淋巴瘤、慢性淋巴细胞白血病及原研利妥昔单抗未在中国获批的类风湿关节炎（RA）适应症，以差异化的开发惠及广泛患者群体。汉利康^®（利妥昔单抗）国内市场的销售推广由江苏复星团队负责，2021年复宏汉霖基于与合作伙伴约定的利润分成安排获得销售收入约人民币5.425亿元，授权许可收入约1040万元。

关于汉曲优^®

复宏汉霖旗下重磅产品汉曲优^®（欧洲商品名：Zercepac^®）于2020年7月及8月先后获得欧盟委员会与中国国家药监局批准上市，为首个中欧双批的国产单抗生物类似药。可用于HER2阳性早期乳腺癌、转移性乳腺癌和转移性胃癌，即涵盖原研已获批准的所有适应症，有望为全球HER2阳性乳腺癌和胃癌患者带来更多治疗选择。2021年，汉曲优^®（曲妥珠单抗，欧洲商品名：Zercepac^®）于中国和欧洲销售规模稳健增长，实现国内销售收入约8.680亿元，较2020年涨幅约692.7%，海外销售收入约6220万元，海外授权许可及研发服务收入约3020万元。

关于汉贝泰^®

复宏汉霖旗下肿瘤领域产品汉贝泰^®于2021年12月正式获得中国国家药监局上市注册批准，可用于治疗：1）转移性结直肠癌；2）晚期、转移性或复发性非小细胞肺癌，为肺癌、结直肠癌患者提供新的优质用药选择。目前，汉贝泰^®联合公司核心免疫治疗产品斯鲁利单抗（创新抗PD-1单抗）在肿瘤免疫联合疗法的临床研究亦在推进中。

Henlius and Eurofarma Entered into a License Agreement for Henlius' 3 Products in Latin America

Shanghai, China, May 11^th, 2022 - Shanghai Henlius Biotech, Inc. (2696.HK) today announced it has entered into a license and collaboration agreement with Eurofarma Laboratórios SA ("Eurofarma"), a leading Brazilian pharmaceutical company with considerable experience in introducing and marketing innovative medical products throughout Latin America, for the development, manufacturing and commercialization in 16 Latin American countries of Henlius' independently developed HANLIKANG (rituximab biosimilar), HANQUYOU (trastuzumab biosimilar, trade name in Europe: Zercepac^®), and HANBEITAI (bevacizumab biosimilar). This collaboration is not only an endorsement of Henlius' product quality and operational strength, but also a continuation of the company's goal of advancing its worldwide footprint, building momentum for the company's evolution from biotechnology to biopharma.

Under the agreement terms, Henlius will receive up to a total of $50.5 million, including a $4.5 million upfront payment. Meanwhile, Eurofarma will acquire exclusive rights to rituximab HANLIKANG in 12 countries, including Mexico, Guatemala and Panama, as well as trastuzumab HANQUYOU in 11 countries, including Mexico, Chile and Ecuador, and bevacizumab HANBEITAI in 15 countries, including Mexico, Argentina and Chile. In addition, Eurofarma will obtain semi-exclusive rights to the three products in Brazil.

Mr. Jason Zhu, President of Henlius , said, "We feel really honored to partner with Eurofarma. Henlius has always adhered to our intention to improve patients' lives by timely providing them with quality and affordable protein therapeutics. Eurofarma has one of the largest sales teams in Latin America. Its robust business network and resources will effectively promote the commercialization of Henlius products in Latin America and the availability to patients. It is hoped that our three products can become effective treatment options for more patients in Latin American countries and light up their lives."

"We are extremely proud of this new partnership, which marks our more robust coverage in biosimilars and confirms our recent moves and work to provide Latin America with the greatest products of the world. We are putting together two of our main strategies to achieve our goals: expanding our presence regionally to increase the revenues from international operations and deploying new technology to the medicine, that definitely helps us become a reference in innovative matter", says Martha Penna, Vice President of Innovation at Eurofarma.

Bearing patients' needs in mind, Henlius has actively expanded the global markets by leveraging its strong product development, manufacturing and quality systems, and commercialization capabilities, as well as joining hands with partners in the value chain. HANQUYOU (trade name in Europe: Zercepac^®), the first Chinese mAb biosimilar approved in both Europe and China, and HANBEITAI are commercialized by the company's in-house team in China market. At present, both 150mg and 60mg dosage forms of HANQUYOU have been included in China's National Reimbursement Drug List (NRDL), benefiting over 50,000 patients to date. HANLIKANG (rituximab injection) is the first-ever China-manufactured biosimilar approved by the National Medical Products Administration (NMPA). As of now, it has benefited more than 100,000 Chinese patients. Meanwhile, Henlius has aggressively pursued international commercialization of HANQUYOU and HANLIKANG. The company actively collaborated with global partners such as Accord Healthcare, Cipla, Mabxience, and the Jacobson Group to bring its HANQUYOU to patients in the United States, Canada, Europe, and other emerging markets, covering over 80 countries and regions worldwide. Zercepac^® is now available in around 20 European nations and regions, including the United Kingdom, Germany, Spain, France, Italy, Ireland, Hungary, and Switzerland. Moreover, the company has also reached a cooperation agreement with Colombian pharmaceutical company Farma de Colombia to promote the commercialization of HANLIKANG in Colombia, Peru, Ecuador and Venezuela. Including the cooperation with Eurofarma, Henlius' products have reached 19 populous countries in Latin America, covering more than 90% of the Latin American population.

About Eurofarma

Since its establishment in 1972, Eurofarma has been operating in the health industry, producing and marketing products and services to improve people's quality of life. Focused on generating shared value, it operates in the areas of Prescription, Non-Prescription, Generic Drugs, Hospital and Oncology. It offers over 700 products, over 2,000 SKUs and serves 42 medical specialties. In Brazil, the company covers 100 therapeutic classes, which represent 70% of the prescriptions in the entire market.

Present in 20 countries, with a manufacturing park in Brazil and plants in six other Latin American countries, it generated net sales of R$ 7.1 billion in 2021, growth of 23% over the previous year, and employs more than 8,100 people.

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 5 products have been launched in China, 1 in Europe, 13 indications approved worldwide, and 2 New Drug Application (NDA) accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name in Europe: Zercepac^®), the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors and its NDA for the treatment of squamous non-small cell lung cancer and extensive small-cell lung cancer (ES-SCLC) are under review. What's more, Henlius has conducted over 20 clinical studies for 12 products and 9 combination therapies.

About HANLIKANG

HANLIKNAG (rituximab) is the company's first proprietary product. It is the first-ever China-manufactured biosimilar approved by the NMPA in accordance with the Technical Guidelines for the Development and Evaluation of Biosimilars (Tentative) issued in 2015. As of now, HANLIKANG has been approved by NMPA for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis for which the originator rituximab has not been approved in China, benefiting a wider patient population with differentiated strategies. The domestic commercialization of HANLIKANG (rituximab) is being handled by Jiangsu Fosun, a subsidiary of Fosun Pharma. In 2021, HANLIKANG received a profit-sharing of RMB 542.5 million from Fosun Pharma and licensing revenue of RMB 10.4 million.

About HANQUYOU

HANQUYOU (trastuzumab, trade name in Europe: Zercepac^®) was successfully launched in China and Europe, becoming the first Chinese mAb biosimilar entering both the EU and China market. It is indicated for the treatment of HER2 positive early breast cancer, metastatic breast cancer and metastatic gastric cancer, which corresponds to all the approved indications of the trastuzumab originator. It will bring more treatment options to patients with HER2 positive breast and gastric cancer worldwide. In 2021, HANQUYOU (trastuzumab, trade name in Europe: Zercepac^®) delivered solid growth in China and Europe, reaching a sales revenue of RMB 868.0 million with a 692.7% YoY increase and RMB 62.2 million from the Chinese market and international market, respectively. The company also received an oversea licensing revenue and revenue from R&D services of RMB 30.2 million.

About HANBEITAI

HANBEITAI (bevacizumab) was approved by the NMPA in December 2021, for the treatment of metastatic colorectal cancer (mCRC) and unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC). Meanwhile, clinical studies of its combination therapy with in-house immunotherapy products serplulimab (anti-PD-1 mAb) are also in progress.

联系方式

媒体：PR@Henlius.com

投资者：IR@Henlius.com